Pilot SMART of a Remotely Delivered, Adaptive Physical Activity Intervention for Breast Cancer Survivors (NCT07706556)
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to evaluate the feasibility of randomizing participants to a "step-up" intervention pathway when they perform \<150 minutes of MVPA at the 6-week data collection burst. Participants who performed \<150 minutes of MVPA at the 6-week data collection burst will be randomized to either continue with the standard intervention or advance to the step-up intervention. The main questions it aims to answer are: 1. What percentage of participants who are eligible for the intervention phase enroll in the intervention phase? 2. Will participants assigned to the "step-up" intervention pathway demonstrate equal or greater rates of study retention and intervention engagement relative to those assigned to the standard intervention arm? 3. What percentage of the sample is performing \>150 minutes accelerometer measured MVPA/week at the intervention mid-point (week 6-data collection burst) and end-of-study (week 12-data collection burst)? 4. Do at least 50% of participants assigned to the "step-up" intervention pathway achieve a clinically meaningful volume of weekly MVPA by 12-weeks follow-up? All participants will: * Be assigned to either the Affect-based exercise prescription or the Effort-based exercise prescription. * Participate in three meetings with the interventionist (an exercise specialist) meant to help them get started increasing weekly exercise. These meetings are the same for all participants. * Be asked to wear an activity monitor and respond to brief surveys for 10 consecutive days at 4 points in time: Baseline, 2weeks, 6weeks, and 12weeks. Some participants (those performing \<150 minutes of MVPA at the 6-week data collection burst) will be assigned to the step-up intervention pathway. Participants assigned to the step-up intervention pathway will complete 3 additional follow-up meetings with the interventionist. During these meetings, the interventionist will help participants identify opportunities to be more active, set goals, and problem solve barriers to action.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (8 items).
Location: Dartmouth-Hitchcock Clinic — Lebanon, New Hampshire
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Non-English speaking/not able to read English
- Evidence of major contraindications for exercise (informed by the 2020 Physical Activity Readiness-Questionnaire (PAR-Q)+)
- Currently pregnant
- History of severe mental illness or currently taking mood stabilizing medications (antipsychotics, anticonvulsants, or lithium)
- Evidence of moderate-severe depressive symptoms (indicated by a score≥ 10 on the Patient Health Questionnaire-8)
- Evidence of moderate-severe cognitive impairment (indicated by a score \< 3 on a 6-item cognitive screener)
- Evidence of clinically significant substance use as indicated by a score of ≥ 2 on the CAGE- AID screener.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Dartmouth-Hitchcock Clinic — Lebanon, New Hampshire
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.